Kornimate/medical-research-clean huggingface dataset:
pilot study of lymphoid tumor microenvironmental dysruption prior to autologous stem cell transplantation

Conditions: Chronic Lymphocytic Leukemia; Lymphoma; Multiple Myeloma

Summary: in order to keep our immune systems healthy over our lifetime, certain cells in the bone marrow and lymph nodes called stromal cells nurture the immune cells and protect them from damage. stromal cells and blood cells communicate using a protein called sdf1a. the investigators think that cancer cells including lymphoma and multiple myeloma can trick the stromal cells into helping them avoid damage from chemotherapy by using sdf1a. plerixafor is a drug developed to block the effects of sdf1a and has been approved by the federal drug administration (fda) for use in humans to help release blood stem cells from the bone marrow for use in transplantation. the use of plerixafor to interrupt communication between stromal cells and cancer has not been approved by the fda and is experimental.


Eligibility criteria:
inclusion criteria: * age 18 years or older * subjects must have documented, relapsed/refractory or high-risk primary lymphoid malignancy * subjects must have evidence of residual disease prior to transplant, but need not have measurable or strictly evaluable disease * subjects must be eligible candidates for high dose chemotherapy with either beam or single-agent melphalan preparative regimens and autologous stem cell transplantation at tufts medical center (see appendix b for anticipated transplant schedules) * subjects must be able to provide informed consent to the research procedure exclusion criteria: * uncontrolled infection * active heart disease as evidenced by myocardial infarction within 6 months, uncontrolled arrhythmia, or angina. * creatinine clearance estimated \< 50 ml/min. * hiv infection or evidence of active chronic hepatitis * unable or unwilling to comply with required study procedures
comparing two types of diets on psychological and gastrointestinal symptoms

Conditions: Irritable Bowel Syndrome

Summary: this pilot study proposes to gain a better understanding of the health benefits of the popular "paleo-diet" in patients with irritable bowel syndrome (ibs) and explore underlying mechanisms of benefit.

in the proposed study, the primary hypothesis is that, compared with a customary diet, consumption of a paleo-diet will improve psychological and gastrointestinal symptoms in patients with irritable bowel syndrome. investigators also hypothesize consumption of the paleolithic diet will result in decreased intestinal permeability, decreased inflammatory markers, and changes in the gut microbiome and microbiologic profiles.

Eligibility criteria:
inclusion criteria: * patients with mild to moderate irritable bowel syndrome (ibs) and mild to moderate anxiety or depression * other causes of bowel symptoms excluded to the satisfaction of the study team * age at least 18 years at initial screening visit * patients who are able to sign and understand the study's informed consent form * patients able to complete all screening evaluations and procedures exclusion criteria: * patients in inpatient hospital care * severe or refractory bowel or psychological symptoms * current consumption of a paleolithic diet * known celiac disease * uncontrolled thyroid disease as indicated by an abnormal thyroid stimulating hormone (tsh) level * uncontrolled diabetes as indicated by a hba1c equal to 6.5 or greater * patients unable to speak english * inability to obtain informed consent * pregnant or nursing women * any condition, which in the opinion of the investigator, would interfere with study requirements
defining circadian metabolism in non-alcoholic fatty liver disease

Conditions: NAFLD

Summary: the investigators will conduct an open label, experimental medicine study exploring the diurnal patterns of hepatic lipid metabolism in nafld and non-nafld participants (determined by transient elastography (te) with controlled attenuation parameter (cap)). we will also determine whether the diurnal patterns of lipid metabolism in nafld participants can be modified using lifestyle and weight loss intervention. fourteen participants without nafld will have morning and evening metabolic investigations (visit 1m \& 1e) to assess for changes in lipid flux pathways across the course of the day. after morning and evening investigations their involvement in the clinical study will then end. seventeen nafld participants will also have identical baseline morning and evening investigation after which they will be enrolled into a 12-week lifestyle and weight loss programme. after 12-weeks, all 17 participants with nafld will have a follow up cap, and morning and evening metabolic investigations (visit 2m \& 2e).


Eligibility criteria:
inclusion criteria: * male or female * bmi 25-50 kg/m2 * age 18-75 years exclusion criteria: * a diagnosis of type 1 diabetes * type 2 diabetes controlled with medications other than metformin (within last 3 months) * shift working patterns in last 3-months or if likely to work shifts during study period. * current or recent (\<3-months) use of weight loss medications * current or recent use of oral contraceptive pill or hormone replacement therapy (within last 3-months) * pregnancy * a blood haemoglobin \<120mg/dl * history of alcoholism or a greater than recommended alcohol intake (recommendations \> 21 units on average per week for men and \> 14 units on average per week for women) * haemorrhagic disorders * treatment with anticoagulant agents * other co-morbidities that in the eyes of the investigators may affect data collection * any medical condition in the opinion of the investigator that might impact upon safety or validity of the results * transient elastography (te) controlled attenuation parameter (cap) of between 216-305 db/m
open and comparative study to measure tolerability and efficacy of taro elixir

Conditions: Acne Vulgaris II or III Degree; Boils

Summary: to measure the efficacy of taro elixir compare with oxytetracycline in the treatment of boils or acne.


Eligibility criteria:
inclusion criteria: * both of gender patient, older than 14 years; * patient with boils or acne vulgaris ii or iii degree; * the score must be at least than 4, for 2 or more question of vas (visual analog scale); * patient that have been used an effective contraceptive method in the last 3 months, including sexual abstinence and that keep using that method during the study until a month after; * patient that have been accepted to participate of the study and signed the informed consent or in case of younger than 18 years, the responsable must read and sign the informed consent. * patient that have been accepted to meet all the visits stipulated at the protocol, whenever the investigator request in . exclusion criteria: * patient of female gender that has been pregnant, breastfeeding or that has not been use a safe contraceptive method (oral contraceptives or barrier methods). sexual abstinence will be accept if the investigator think that it is relevant. * patient that has been use antiandrogens (cyproterone, finasteride, flutamide, tamoxifen, spironolactone); * patient with acne i or iv degree; * patient that has been receive some treatment for acne as antibiotics, corticosteroid or any medicine that can maybe interfere in the study results: a month for systemic treatment or two weeks for topic treatment, before inclusion or during the study; * patient that received treatment with oral retinoids within 6 months before the inclusion and during the study; * patient that had a known decompensated diabetes history; * patient with immunodeficiency and liver, renal, cardiac, digestive, metabolic, endocrinological, hematological, neurological or psychiatric disorders, evaluated through anamnesis by the investigator, tha can maybe interfere on the study evaluation. even the patient with facial dermatoses such as psoriasis, acne rosacea, allergic dermatitis, skin infections caused by fungi, bacteria and viruses; * patient with alcoholism history, illicit drugs use, psychological ou emotional problems that can maybe void the informed consent or limit the capacity of the patient follow the protocol requirements ; * patient hypersensitive to any one of the medicine components; * patient that have been used any drug under search, 3 months before the visit number one.

Keywords: acne vulgaris boil taro elixir
use of symbicort or pulmicort to treat viral-mediated asthma exacerbations

Conditions: Asthma

Summary: this is an investigator-initiated study in which dr. nadeau wrote the protocol and received funding from an astra zeneca grant to direct, perform, and monitor the study on her own with stanford staff. we hypothesize that the budesonide/formoterol combination improves the efficacy of budesonide alone.

the study was designed such that 30 participants would be consented/enrolled into the trial. the intervention would only be applied if the participant developed a viral illness that met eligibility criteria during the study period. only 10 of the 30 ppt. consented/enrolled developed a virus and were then treated according to study arm. a more detailed description can be obtained by contacting astra zeneca

Eligibility criteria:
inclusion criteria: subjects will be considered for inclusion in this study based on meeting all of the following criteria: 1. male or female, aged 12 to 65 years 2. subjects with mild to moderate asthma as determined by nhlbi 2007 guidelines 3. subjects with exacerbation of their asthma symptoms by nhlbi 2007 guidelines 4. ige level at study entry less than 50 iu/ml 5. men and women of reproductive potential who document use of adequate contraception during the study and for 3 months after the conclusion of treatment with study drug/placebo 6. historical documentation of asthma in the patient's medical record. the patient should have 6 months or more of asthma medication and management by a stanford physician. 7. women of childbearing potential who have a negative pregnancy test (urine or serum) at the time of study entry 8. subject's guardians who are capable of understanding the purpose and risks of the study and who sign a statement of informed consent for the study exclusion criteria: subjects will be ineligible for this study based on any one of the following criteria: 1. with a chronic or acute disease that might interfere with the evaluation of symbicort or pulmicort flexhaler therapy 2. pregnancy or lactation 3. current or prior malignancies (excluding non-melanoma skin carcinoma or carcinoma in situ of the cervix that has been adequately treated) 4. history of infection with human immunodeficiency virus (hsc-1), hepatitis b virus (hbv), or hepatitis c virus (hcv); or hepatitis a virus (hav) 5. infections that require intravenous antibiotic therapy 6. significant organ dysfunction, including cardiac, renal, liver, cns, pulmonary, vascular, gastrointestinal, endocrine, or metabolic (e.g., creatinine \>1.6 mg/dl; alt or ast \> 1.5x the upper limit of normal; history of myocardial infarction, congestive heart failure, or arrhythmias within 6 months prior to study entry) 7. treatment with a humanized or chimeric antibody therapy within 4 weeks prior to study entry 8. treatment with any investigational drugs or therapies within 2 weeks prior to study entry 9. any use of oral, systemic corticosteroids within 2 weeks prior to study entry

Keywords: asthma
observational non-interventional study with spiriva respimat in copd patients

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: this observational non-interventional study is designed to demonstrate the improvement of physical function in copd patients on treatment with spiriva respimat and allows adverse events to be recorded and evaluated.


Eligibility criteria:
inclusion criteria: copd patients who require treatment with longacting anticholinergic exclusion criteria: patients cannot be recruited if any of the general or specific contraindications listed in the patient information leaflet or the summary of product characteristics applies. spiriva® respimat® is contraindicated in patients with hypersensitivity to tiotropium bromide, atropine or its derivatives, e.g. ipratropium or oxitropium or to any of the excipients.

Keywords: chronic obstructive pulmonary disease (copd)
piloting and evaluation of a group intervention for people with psychosis designed to boost access and usage of ict

Conditions: Serious Mental Illness

Summary: participants will be given access to a tablet. with this technology, participants will be invited to set personal goals related to using this technology to foster social connection and community participation. participants will attend a group led by two occupational therapy students and an occupational therapist focused on digital literacy and how to use technology to meet their goals. in the group, participants will learn how to use their device and how to safely access various online resources and tools to support their recovery. participants will keep their provided devices upon conclusion of the group sessions. participants will complete quantitative outcome measures at the start and end of the group intervention. participants will be invited to attend a semi-structured interview one month after the completion of the group about their experiences with the program.


Eligibility criteria:
inclusion criteria: * specific inclusion criteria for participants in this study will include being diagnosed with a psychotic disorder, living in the hamilton area, ability to communicate in english, and having more than one episode of psychosis. every effort will be made to recruit participants from study with hireb approvals #17367 and #18549, as indicated in that study's previous consent form, for those that have consented to be contacted for future research. exclusion criteria: * exclusion criteria include currently experiencing an acute psychotic episode or medical condition that would render them incapable of meaningfully participating in the study.

Keywords: information and communication technology recovery social connection community participation
stem cell transplantation with nicord® (omidubicel) vs standard ucb in patients with leukemia, lymphoma, and mds

Conditions: Hematological Malignancies; Acute Lymphoblastic Leukemia (ALL); Acute Myelogenous Leukemia (AML); Chronic Myelogenous Leukemia (CML); Myelodysplastic Syndrome (MDS); Lymphoma; Acute Leukemia

Summary: this study is an open-label, controlled, multicenter, international, phase iii, randomized study of transplantation of nicord® versus transplantation of one or two unmanipulated, unrelated cord blood units in patients with acute lymphoblastic leukemia or acute myeloid leukemia, myelodysplastic syndrome, chronic myeloid leukemia or lymphoma, all with required disease features rendering them eligible for allogeneic transplantation.

successful blood and marrow transplantation (bmt) requires the infusion of a sufficient number of hematopoietic stem/progenitor cells (hspcs), capable of both homing to the bone marrow and regenerating a full array of hematopoietic cell lineages with early and late repopulating ability in a timely fashion. a major drawback of umbilical cord blood (ucb) is the low stem cell dose available for transplantation, compared to mobilized peripheral blood (pb) or bone marrow. this low stem cell dose can compromise the chances of engraftment and contributes to delayed kinetics of neutrophil and platelet recovery, as well as other transplant outcomes. the aim of ex vivo expansion of cord blood is to provide a graft with sufficient numbers of cells that have rapid and robust in vivo neutrophil and platelet producing potential to enable successful transplantation. nicord® is a stem/progenitor cell-based product composed of ex vivo expanded allogeneic cells from one entire unit of ucb. nicord® utilizes the small molecule nicotinamide (nam), as an epigenetic approach to inhibit differentiation and to increase the migration, bone marrow (bm) homing and engraftment efficiency of hematopoietic progenitor cells (hpc) expanded in ex vivo cultures. the chief aim of the study is to compare the safety and efficacy of nicord® single ex-vivo expanded cord blood unit transplantation to unmanipulated cord blood unit transplantation in patients with hematological malignancies following conditioning therapy.

Eligibility criteria:
inclusion criteria: * applicable disease criteria * patients must have one or two partially hla-matched cbus * back-up stem cell source * adequate karnofsky/lansky performance score * sufficient physiological reserves * signed written informed consent exclusion criteria: * hla-matched donor able to donate * prior allogeneic hsct * other active malignancy * active or uncontrolled infection * active/symptoms of central nervous system (cns) disease * pregnancy or lactation
persistence of antibodies after meningococcal vaccine pf-06866681 in healthy children

Conditions: Infections, Meningococcal

Summary: the purpose of this study is to evaluate the long-term antibody persistence as well as safety of gsk biologicals' menacwy-tt vaccine versus meningitec up to 6 years after booster vaccination administered in healthy 5 year old children in the study menacwy-tt-048 ext: 039 y2, 3, 4, 5 (nct00955682), who were primed with the same vaccine in the study menacwy-tt-039 (nct00474266) at 12 through 23 months of age.

the subjects in this study will be allocated to the same groups as in study menacwy-tt-048 ext: 039 y2, 3, 4, 5 (nct00955682). no vaccine will be administered during this long-term persistence study.

Eligibility criteria:
inclusion criteria: all subjects must satisfy all the following criteria at study entry: * subjects' parent(s)/legally acceptable representative(s) \[lar(s)\] who, in the opinion of the investigator, can and will comply with the requirements of the protocol. * a male or female who has received primary and booster vaccination with the menacwy-tt or meningitec vaccines in studies menacwy-tt-039 (109670) and menacwy-tt-048 ext: 039 y2, 3, 4, 5 (112036), respectively. * written informed consent obtained from the parent(s)/lar(s) of the subject. * healthy subjects as established by medical history and clinical examination before entering into the study. exclusion criteria: the following criteria should be checked at the time of study entry. if any exclusion criterion applies, the subject must not be included in the study: * child in care. * history of meningococcal disease. * administration of a meningococcal polysaccharide or a meningococcal polysaccharide conjugate vaccine outside of studies menacwy-tt-039 (109670) and menacwy-tt-048 ext: 039 y2, 3, 4, 5 (112036). * any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy.

Keywords: healthy immunogenicity children neisseria meningitidis long-term antibody persistence safety serogroups a, c, w-135, and y
neopatch used as adjunct in foot and ankle tendon surgery

Conditions: Tendinopathy; Tendon Tear; Tendon Injuries; Foot Ankle Injuries

Summary: this study is a prospective, single center, postmarket study to evaluate the safety and effectiveness of neopatch used as a tissue cover in foot and ankle tendon revision and repair surgery.

this study is a prospective, single center, postmarket study to evaluate the safety and effectiveness of neopatch used as a tissue cover for chronically injured tendons requiring surgical revision. neopatch is a tissue covering derived from terminally sterilized, dehydrated human placental membrane tissue comprised of both amnion and chorion. candidates for this study are patients presenting with chronic tendon pain that are being evaluated for primary tendon revision surgery following failure of standard of care or immediate need for surgery, as determined by the investigator. consented patients will receive neopatch as an adjunct to their foot or ankle tendon revision; neopatch will be wrapped around the tendon immediately prior to closure. the study will be divided into two phases: screening and follow-up. the study will include prospective patient evaluations at scheduled clinic visits and ultrasound appointments for a maximum of 12 visits over 12 months. patient history, medications, self-reported pain, tendon status, and adverse events will be collected on all patients consented and enrolled into the study.

Eligibility criteria:
inclusion criteria: * chronic tendinopathy requiring surgical revision in the opinion of the investigator as defined in appendix g. * intention to schedule surgical revision. ≥ 18 years. * free from clinical signs of infection at time of screening and at time of surgical intervention. * target tendon is one of the following: achilles, extensor digitorum longus, extensor hallucis brevis, extensor hallucis longus, flexor digitorum longus, flexor hallucis longus, tibialis anterior, tibialis posterior, peroneus longus, peroneus brevis, peroneus tertius. * able and willing to provide consent and comply with protocol. exclusion criteria: * history of surgical intervention involving target tendon. * tendon injury is acute in nature. * current participation in another clinical study. * currently receiving radiation or chemotherapy. * diagnosis of autoimmune connective tissue disease requiring systemic immunomodulatory therapy; stable nsaid doses for mild rheumatoid arthritis permitted. * use of biomedical growth factor within previous 30 days. * pregnant or breastfeeding or planning on becoming pregnant or unwilling to use medically acceptable methods of birth control. * taking medications considered to be immune system modulators within previous 30 days. * patient taking specific cox-2 inhibitors within previous 30 days. * currently being treated with an investigational device or drug (within 3 months prior to surgery). * allergy, intolerance or hypersensitivity to any components or packaging of the product.
assessing the risk of cmv infection of the renal transplant about r + by cellular immunity analyzed by the quantiferon ®-cmv test.

Conditions: Renal Transplant Recipient; Immunized Against the Cytomegalovirus

Summary: cytomegalovirus (cmv) infection was observed in over 30% of organ recipients with high morbidity. moreover, no prophylaxis, 75% r + d-transplanted, 55%, r + d + and d-25% r + develop cmv. the number of available antiviral drugs is reduced and noticeable side effects (neutropenia, renal toxicity) lead to premature discontinuation of therapy or the use of reduced doses that promote non-response to treatment and the emergence of resistance. in case of neutropenia, there are more an increased risk of secondary rejection due to the reduction of immunosuppressive treatment rendered necessary by the haematological reached. rational use of these molecules is necessary with essential today as the optimal duration of prophylaxis primary issues and the prophylaxis of recurrences in case of cmv infection reported in.

quantiferon-cmv ® is a fast and standardized test that evaluates the cmv specific cellular immunity measuring the amount of secreted interferon gamma (ifn gamma) in plasma by elisa. it uses more epitopes of proteins including cmv glycoprotein b (gb), protein ie-1 and protein pp65 and protein pp50, which are specific for (human leukocyte antigen) hla class i. pretreatment of the sample is simple and plasma can be stored, frozen, for a delayed dose of interferon.

Eligibility criteria:
inclusion criteria: * renal transplant recipient * immunized against the cytomegalovirus exclusion criteria: * not willing to participate, no health insurance * clinical evidence of active viral infection * renal transplant recipient whose treatment includes induction antilymphocyte antibodies

Keywords: renal transplant cmv test quantiferon-cmv